This invention relates to a method and apparatus for sealing luminal tissue, and more particularly, to obtaining hemostasis in the femoral groin after cannulation of the femoral artery for the purpose of heart catheterization or coronary angioplasty.
The femoral artery is a very high pressure artery which requires that direct pressure be applied above the puncture site for twenty to thirty minutes in order to guarantee that hemostasis (bleeding has stopped) is attained. For example, if an arterial sheath is removed from the femoral artery in the groin and no attempt to apply pressure is made, this patient would bleed to death in a matter of minutes.
To prevent this from happening, one must remain at the groin site holding very firm pressure with gloved hands directly above the puncture site for twenty to thirty minutes. As a result, fatigue, numbness, stiffness and pain occur in the fingers, hands, wrist and forearms of the practitioner performing this procedure. Also, there is the possibility that a glove could have or develop a tear, thereby allowing direct pressurized digital (fingers) contact with bodily fluids (blood). Extensive use of the procedure over a long period of time without the aid of any assist devices, can cause extensive injury to the user. One such injury is Carpal Tunnel Syndrome.
One possible solution for sealing arteries is described in U.S. Pat. No. 3,411,505. This device has a handle at one end and a rod at its other end which contacts internal arteries to be sealed.
A drawback to this device is that it is hard to balance on the artery when supported by hand and may tend to fall over. Another drawback is that the device requires excessive hand pressure to seal the wound, resulting in the wrist of the user becoming tired when pressure is applied for a long time. This device may also require sterilization after the procedure possibly requiring disposal of the device. Further, the device was not designed for internal use and may not be able to apply sufficient pressure to an artery when used externally.